Inspections, Compliance, Enforcement, and Criminal Investigations
American Optisurgical Inc 3-16-2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Los Angeles District
RETURN RECEIPT REQUESTED
March 16, 2009
Herbert Cameron III, President
American Optisurgical, Inc.
25501 Arctic Circle Drive
Lake Forest, CA 92630
Dear Mr. Cameron:
During an inspection of your medical device firm located in Irvine, California, from October 21 through November 5, 2008, our investigator determined that your firm manufactures and distributes the Vizual Phacoemulsification System, and performs warranty/repair services for the Horizon Phacoemulsification System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body of man or other animals.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act [21 U.S.C. § 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received a response from Herbert Cameron III, President, dated November 14, 2008, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to implement complaint handling procedures for receiving and evaluating complaints, as required by 21 C.F.R. 820.198. Specifically, related to Horizon Phacoemulsification Systems:
a. Your firm did not follow the Complaint Handling/Incident Reporting procedure (document
no. (b)(4) to receive, investigate and document a complaint that resulted in the identification of a software malfunction and subsequent revision of software.
b. Your firm did not follow the Customer Complaints procedure (b)(4) receive, investigate and document a complaint of a blank screen that resulted in the replacement of the main PCB on the unit.
Your response dated November 14, 2008 is not adequate because although you have indicated that you will document complaints for each of the above incidents, you have not provided the complaint documentation promised, nor have you indicated that complaint handling personnel, and management, as necessary, have been adequately trained (or retrained) in your complaint handling/incident reporting procedure to prevent this deficiency from recurring.
2. Failure to follow procedures for the validation or verification and review of design changes before their implementation, as required by 21 C.F.R. 820.30(i).
Specifically, software (version (b)(4)) used in Horizon Phacoemulsification System was validated on 1/16/07. There is no engineering change order nor verification or validation for changes made to this software on 5/8/07 (version (b)(4)), as required by the firm's procedures "Document Control" (document number (b)(4)) and "Design and Development" (document number (b)(4)).
This is a repeat observation from the November 2004 inspection. Your response dated November 14, 2008 is not adequate because you have not provided the engineering change order verification documentation as promised, nor have you indicated that the appropriate personnel have been retrained in the deficient procedures cited.
3. Failure to implement procedures for acceptance activities, as required by 21 C.F.R. 820.80(a).
Specifically, "Final Acceptance Inspection" ((b)(4)) procedure indicates that QA is responsible for final inspections and the release of all finished products; however, final release of finished devices, including Vizual Phacoemulsification Systems, are currently inspected, reviewed and released by manufacturing and customer service personnel without QA review and approval.
Your response dated November 14, 2008 is not adequate because you have not included documentation of your promised corrections, including updating job descriptions, training documentation, and revised responsibility documentation for finished device inspection and release.
4. Failure to follow procedures for the control of products that do not conform to specifications, as required by 21 C.F.R. 820.90(a).
Specifically, the "Nonconforming Material" procedure((b)(4)) was not followed for the documentation, review and disposition of nonconforming components identified on receiving inspection reports # (b)(4) and (b)(4). These components are used in the Vizual Phacoemulsification System.
Your response dated November 14, 2008 is not adequate because you have not indicated that the employee who failed to follow written procedures was retrained. In addition, you have not provided the documents promised as verification of your corrections, including the revised receiving inspection procedure.
5. Failure to establish and maintain procedures for validating the device design, including documentation of the appropriate complete risk analysis, as required by 21 C.F.R. 820.30(g). Specifically, your risk analysis is incomplete for the Horizon Phacoemulsification System that is dated 6/18/04. Risk Analysis was not re-evaluated for multiple software changes that occurred after 6/04, including the bug fixes that were performed on 1/11/07 and 5/8/07.
Your response dated November 14, 2008 is not adequate. No documents (i.e. risk analyses) have been provided to document your promised corrections.
Our inspection also revealed that your Horizon Phacoemulsification System device is misbranded under section 502(t)(2) of the Act, [21 U.S.C. 352(t)(2)], in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:
1. Failure to submit a written report to FDA of any correction or removal of a device initiated by the manufacturer where the correction or removal was initiated to reduce a risk to health posed by the device, or to remedy a violation of the act caused by the device which may present a risk to health, as required by 21 C.F.R. 806.10.
Specifically, the Horizon Phacoemulsification System software was revised on 51 8/07 to correct a malfunction that can cause the unit to pause when pressure goes above 300 mmhg in burst mode. When vacuum pressure is set above 300 mmhg (by pressing on the foot pedal) and the unit is set to operate in burst mode, the unit (including handpiece) can pause. The malfunction could lead to a delay in surgery, injury to the eye, or other serious adverse event. This correction was not reported to FDA.
Your response dated November 14, 2008 is not adequate, because although you indicate that you will contact the owners of all affected units, you still have not reported this correction to FDA per the Corrections and Removals regulation. The FDA also recommends that you contact the FDA Recall Coordinator for your District and provide recall data as outlined in 21 C.F.R. Part 7.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised, of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your written reply should be addressed to:
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions regarding this letter, please contact Mr. Robert B. McNab, Compliance Officer at 949-608-4409.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483, (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Alonza E. Cruse
Cc: California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 9974 13
Sacramento, CA 95899-7413